E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic Lupus Erythematosus |
Lupus Eritematoso Sistémico |
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E.1.1.1 | Medical condition in easily understood language |
Systemic Lupus Erythematosus or SLE, is an inflammatory disease caused when the immune system attacks its own tissues. |
Lupus Eritematoso Sistémico o LES, es una enfermedad inflamatoria causada cuando el sistema inmune ataca sus propios tejidos. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042947 |
E.1.2 | Term | Systemic lupus erythematosus synd |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To characterize the long-term safety and tolerability of BMS-986165 in subjects with SLE |
Caracterizar la seguridad y la tolerabilidad a largo plazo de BMS 986165 en pacientes con LES |
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E.2.2 | Secondary objectives of the trial |
Efficacy: To characterize the long-term maintenance of response of BMS-986165 in the treatment of subjects with SLE
To characterize patient-reported outcomes in subjects with SLE on long-term BMS-986165 therapy
Pharmacokinetic: To explore long-term pharmacokinetics of BMS-986165
Pharmacodynamic: To explore long-term pharmacodynamics of BMS-986165 |
Eficacia: Caracterizar el mantenimiento a largo plazo de la respuesta a BMS-986165 en el tratamiento de pacientes con LES
Caracterizar los resultados comunicados por pacientes en pacientes con LES en tratamiento con BMS-986165 a largo plazo
Farmacocinética: Explorar la farmacocinética a largo plazo de BMS-986165
Farmacodinámica: Explorar la farmacodinámica a largo plazo de BMS-986165 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Signed Written Informed Consent 2) Type of Subject and Target Disease Characteristics a) Completion of Study IM011021 through the protocol-required treatment period, and currently receiving blinded study drug 3) Reproductive Status a) Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of study drug. b) Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the study period. c) WOCBP must agree to use correctly a highly effective method(s) of contraception for the duration of treatment with study drug(s) BMS-986165 plus 5 half-lives of study drug (3 days) plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion (total of 33 days after last dose of study drug). WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements, but must still undergo pregnancy testing as described in protocol APPENDIX 4. d) Male subjects who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (APPENDIX 4) for the duration of treatment with study treatment BMS-986165 plus 5 half-lives of the study (3 days) or 3 days post-treatment completion. In addition, male subjects must be willing to refrain from sperm donation during this time. |
1) Consentimiento informado escrito firmado 2) Tipo de sujeto y características de la enfermedad objeto del estudio a) Haber finalizado el estudio IM011021 durante el período de tratamiento exigido por el protocolo y estar recibiendo actualmente el fármaco del estudio con enmascaramiento 3) Estado reproductivo a) Mujeres en edad fértil (MEEF) deben dar resultado negativo en una prueba de embarazo en urina (sensibilidad mínima de 25 IU/L o unidades equivalentes de gonadotropina coriónica humana [GCH]) dentro de las 24 horas previas al inicio del fármaco del estudio. b) Las mujeres no deben estar embarazadas, en período de lactancia o planeando un embarazo durante el período del estudio. c) MEEF deben comprometerse a utilizar correctamente métodos anticonceptivos altamente eficaces mientras dure el tratamiento con el fármaco BMS-986165 más 5 semividas del fármaco del estudio (3 días) más 30 días (duración del ciclo ovulatorio) hasta un total de 33 días tras la finalización del tratamiento (en total, 33 días tras la última dosis de fármaco del estudio). Las MEEF que, de forma continua, no sean heterosexualmente activas estarán exentas de cumplir los requisitos anticonceptivos, pero aun así deberán someterse a las pruebas de embarazo que se describen en el APÉNDICE 4 del protocolo. d) Pacientes varones que sean sexualmente activos con MEEF deben comprometerse a seguir las instrucciones sobre métodos anticonceptivos (APÉNDICE 4) durante el tratamiento con el fármaco del estudio BMS-986165 más 5 semividas del fármaco del estudio (3 días) o 3 días tras finalizar el tratamiento. Además, los pacientes masculinos deberán abstenerse de donar esperma durante este periodo. |
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E.4 | Principal exclusion criteria |
1) Medical History and Concurrent Diseases a) Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason 2) Findings Related to Possible Tuberculosis (TB) Infection a) Evidence of active TB |
1) Historial médico y enfermedades concomitantes a) Cualquier enfermedad o afección que, en opinión del investigador, pudiera hacer que el sujeto no sea apto para este estudio, pudiera interferir con la interpretación de los resultados del estudio o de la seguridad del sujeto o que el investigador considere inaceptable por cualquier otra razón 2) Hallazgos relacionados con una posible infección por tuberculosis (TB) a) Evidencia de TB activa |
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E.5 End points |
E.5.1 | Primary end point(s) |
Adverse events and serious adverse events, vital sign measurements, and laboratory parameters |
Eventos adversos y eventos adversos graves, mediciones de constantes vitales y parámetros de laboratorio |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the study |
A lo largo del estudio |
|
E.5.2 | Secondary end point(s) |
Efficacy: CLASI response - 40-joint count for tender, swollen, and tender + swollen joints - SRI(4) response - BICLA response - PGA - Corticosteroid use (yes/no) - Corticosteroid dose ≤7.5 mg/day (yes/no) - Flare Analysis o Time to first flare o Number and frequency of flares o Flares leading to hospitalization - SDI total score - BILAG response - SLEDAI-2K score - LLDAS response - PROMIS Fatigue Short Form 7a score
Pharmacokinetic: - Plasma concentrations of BMS-986165
Pharmacodynamic: - dsDNA, CRP, Complement levels, UPCR |
Eficacia: Respuesta CLASI -recuento de 40 articulaciones para articulaciones sensibles, hinchadas y sensibles+hinchadas -respuesta SRI(4) -respuesta BICLA -VGM -uso de corticoesteroides (si/no) -dosis de corticoesteroides ≤7.5 mg/día (si/no) -Análisis de reagudizaciones o Tiempo hasta la primera reagudización o Número y frecuencia de reagudizaciones o Reagudizaciones que provocan hospitalización -puntuación total de SDI -respuesta BILAG -puntuación SLEDAI-2K -respuesta LLDAS -puntuación del formulario breve de fatiga PROMIS 7a |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Efficacy - Throughout the study Pharmacokinetics - at Weeks 0, 4, 8, 24, 48 and 108 Pharmacodynamics - at Weeks 0, 4, 8, 12, 36, 60, 84 and 108 |
Eficacia - A lo largo del estudio Farmacocinética - en las semanas 0, 4, 8, 24, 48 y 108 Farmacodinámica - en las semanas 0, 4, 8, 12, 36, 60, 84 y 108 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
diferentes dosis del mismo MI |
different dosage of the same IMP |
|
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 48 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Brazil |
Canada |
Colombia |
France |
Germany |
Hungary |
Israel |
Korea, Republic of |
Mexico |
Poland |
Romania |
Russian Federation |
Spain |
Taiwan |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Última Visita Último Paciente (UVUP) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |